PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
This recall has been terminated (originally issued January 10, 2018).
- Company
- Ethicon, Inc. Us
- Recall Initiated
- January 10, 2018
- Terminated
- April 11, 2019
- Recall Number
- Z-1338-2018
- Quantity
- 7020
- Firm Location
- Somerville, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Distribution
Distribution US Nationwide, Canada, India, and Colombia.
Lot / Code Info
Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459
Root Cause
Process control
Action Taken
On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required: 1. Examine inventory and quarantine all affected product 2. Communicate this recall notice to all affected personnel at facility, or other affected facilities. 3. Complete the business reply form attached to the recall letter. 4. Keep the recall notice posted visibly at facility and maintain a copy with your records 5. Return unused product to recalling firm by April 13, 2018. For further assistance contact 1-855-215-5039.